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A Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Safinamide, as add-on Therapy, in Idiopathic Chinese Parkinson's Disease (PD) Patients With Motor Fluctuations Treated With Stable Doses of Levodopa

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Trial Profile

A Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Safinamide, as add-on Therapy, in Idiopathic Chinese Parkinson's Disease (PD) Patients With Motor Fluctuations Treated With Stable Doses of Levodopa

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 22 Mar 2024

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At a glance

  • Drugs Safinamide (Primary) ; Levodopa
  • Indications Parkinson's disease
  • Focus Registrational; Therapeutic Use
  • Acronyms XINDI Study
  • Sponsors Zambon SpA

Most Recent Events

  • 09 Dec 2023 Results of post hoc analysis of SETTLE and XINDI trial assessing the effects of safinamide in chinese and non-chinese patients with parkinson's disease (440 non-Chinese and 109 Chinese patients in the SETTLE study, and 305 Chinese patients in the XINDI trial ) published in the Advances in Therapy.
  • 08 Nov 2022 Primary endpoint (Change from baseline to week 16 in the mean total daily OFF time, as assessed by 24-hour patient diary cards, of safinamide 100 mg/day compared to placebo, given as add-on therapy in PD patients with motor fluctuations on stable doses of L-dopa.)has been met.
  • 08 Nov 2022 Results assessing efficacy and safety of safinamide as an add-on to levodopa in Chinese patients with Parkinson's disease with motor fluctuations published in the CNS Drugs

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